CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN

{0}------------------------------------------------ ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ## A. Name, Address, Phone and Fax Number of Applicant Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-8050 919-433-4996 Fax: ## B. Contact Person Amanda Webb Regulatory Affairs Specialist ## C. Date Prepared February 5, 2013 ## D. Device Name | Trade Name: | ConchaTherm Neptune Heated Humidifier | |-----------------------|---------------------------------------| | Common Name: | Respiratory Gas Humidifier | | Product Code: | BTT | | Regulation Number: | 868.5450 | | Classification: | II | | Classification Panel: | Anesthesiology | | Trade Name: | ConchaSmart Column | | Common Name: | Respiratory Gas Humidifier | | Product Code: | BTT | | Regulation Number: | 868.5450 | | Classification: | II | | Classification Panel: | Anesthesiology | | Trade Name: | Comfort Flo Humidification System | | Classification Name: | Respiratory Gas Humidifier | | Product Code: | BTT | | Regulation Number: | 868.5450 | Anesthesiology II Classification: Classification Panel: {1}------------------------------------------------ ## E. Predicate Device This submission demonstrates substantial equivalence to the following predicate devices: - . ConchaTherm Neptune Heated Humidifier - K063758 - . Minimal Compliance Column - K993355 - Comfort Flo Humidification System K061736 ● ### F. Device Description The ConchaTherm Neptune Heated Humidifier is an active heated humidifier designed to provide heat and moisture to the medical gases delivered to a patient through continuous flow, invasive ventilation or non-invasive ventilation. The ConchaSmart Column is an accessory to the ConchaTherm Neptune Heated Humidifier. It is a single use, disposable humidifier cartridge which is intended for neonatal, infant, pediatric, and adult patients requiring heated humidification. The ConchaSmart Column is used by inserting the column into the center of the ConchaTherm Neptune. The Comfort Flo Humidification System is intended to deliver heated and humidified respiratory gases to spontaneously breathing patients. The Comfort Flo Humidification System is designed to be used in conjunction with the ConchaTherm Neptune Heated Humidifier for neonate/infant, pediatric, and adult populations. The Comfort Flo Humidification System includes a Heated Wire Breathing Circuit, a ConchaSmart Column, and various Class I exempt accessories. ## G. Indications for Use #### ConchaTherm Neptune Heated Humidifier: The ConchaTherm® Neptune TM is a respiratory humidifier designed to heat and humidify respiratory gases delivered via endotracheal tubes, nasal cannula or face masks to adult, pediatric, infant and neonatal patients. This system may be used with either conventional (non-heated wire) breathing circuits or compatible (21-volt) Hudson Respiratory Care Incorporated (RCI) heated-wire circuits. The ConchaTherm® NeptuneTM can be used with ventilators, continuous flow systems, oxygen diluters and blenders, adjustable nebulizer adapters for aerosol therapy, or nonflammable anesthesia gases to help maintain patient body temperature. #### ConchaSmart Column: When used with the Hudson RCI ConchaTherm Neptune Heated Humidifier and Hudson RCI ventilator circuits, the ConchaSmart Column provides heated humidification for patients with and without an artificial airway in place. #### Comfort Flo Humidification System: To provide a continuous flow of heated and humidified gas to spontaneously breathing patients. {2}------------------------------------------------ ## H. Technological Characteristics Comparison to the predicate The proposed ConchaTherm Neptune Heated Humidifier, ConchaSmart Column and Comfort Flo Humidification System are substantially equivalent to the predicate devices listed above in that the indications for use, the intended use, and fundamental scientific technology remain unchanged. The following tables summarize the technological differences between the proposed and predicate devices. ### ConchaTherm Neptune | Different Technological Characteristic | Predicate Device | |------------------------------------------------------------------|--------------------------------------------------------| | Ability to side mount the unit | Only allowed for rear mounting the unit | | Heated Wire Subglottic: 32° - 40°C<br>(Intubated Mode) | Heated Wire Subglottic: 32° - 39°C<br>(Intubated Mode) | | Supraglottic (Non-Invasive): 28° - 37°C | Supraglottic (Non-Invasive): 30° - 37°C | | Continuous Flow Applications 1-60LPM | Continuous Flow Applications 1-40LPM | | Compliant with ISO 8185:2007 | Compliant with ISO 8185:1997 | | Low Water Notification | Does not have a low water notification | | Auto Settings Mode - allows clinician to<br>set default settings | Does not allow clinician to set default<br>settings | #### ConchaSmart Column | Different Technological Characteristic | Predicate Device | |-----------------------------------------|--------------------------------------| | Includes ability to trigger low water | Does not interact with humidifier to | | notification in the ConchaTherm Neptune | provide a low water notification | | Labeled for 30 day Useful Life | Not labeled for useful life | ## Comfort Flo Humidification System | Different Technological Characteristic | Predicate Device | |--------------------------------------------------------------------------------|----------------------------------------------------------------------------| | Includes above ConchaSmart Column | Included the Comfort Flo Column | | Additional product offering with a<br>corrugated heated wire breathing circuit | Only included a smooth bore PVC heated<br>wire breathing circuit | | Shelf Life on corrugated Comfort Flo<br>Humidification System | Does not include a shelf life on full<br>Comfort Flo Humidification System | | Rated flow for adults is 1-60 LPM | Rated flow for adults is 1-40LPM | | Labeled for 30 day Useful Life | Tested but not labeled for useful life | ## I. Performance Data The following testing was performed on the proposed devices. - ISO 8185 . - IEC 60601-1 . - IEC 60601-1-8 . - IEC 60601-1-4 - Biocompatibility . - o ISO 10993-3 - o ISO 10993-5 {3}------------------------------------------------ - o ISO 10993-6 - o ISO 10993-10 - . Sterility - o ISO 11137-1 - o ISO 11137-2 - . Shelf life - Useful life . - Software Verification and Validation ● ## J. Conclusion The device data and test results demonstrate that the device is as safe and as effective as the predicate device and therefore substantially equivalent. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The logo is presented in black and white. Public Health Service Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 6, 2014 Teleflex Medical Incorporated Ms. Amanda Webb Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709 Re: K131912 Trade/Device Name: ConchaTherm Neptune Heated Humidifier ConchaSmart Column Comfort Flo Humidification System Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: February 10, 2014 Received: February 11, 2014 Dear Ms. Webb: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {5}------------------------------------------------ Page 2 - Ms. Webb Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Image /page/5/Picture/7 description: The image contains a combination of text and graphic elements. The text includes "Tejashri Purohit-Sheth, M.D.", "Clinical Deputy Director", and "DAGRID". There is also a signature present. The graphic elements include a geometric shape resembling a stylized triangle or pyramid, and the word "FOR" is visible in the lower right corner. Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure Sincerely yours, {6}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K 131912 #### Device Name Comfort Flo Humidification System Indications for Use (Describe) To provide a continuous flow of heated and humidified gas to spontaneously breathing patients. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY -్లు గ్రామం నుండి 10 కి.మీ. దూర Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Image /page/6/Picture/12 description: The image shows a logo with the letters "FM" in a stylized, geometric font. The letters are outlined with multiple layers, creating a three-dimensional effect. The overall design is modern and abstract. ## Anya C. Harry -S 2014.03.05 14:12:41 -05'00' This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (1/14) 15C Publishing Sen ices (101) 43-6740 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {7}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K131912 Device Name ConchaSmart Column #### Indications for Use (Describe) When used with the Hudson RCI ConchaTherm Neptune Heated Humidifier and Hudson RCI ventilator circuits, the ConchaSmart Column provides heated humidification for patients without an artificial airway in place. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY . " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Image /page/7/Picture/12 description: The image shows the letters FDA in a stylized, outlined font. The letters are formed by multiple parallel lines, giving them a layered or stacked appearance. The overall design is simple and graphic, with a focus on the bold, geometric shapes of the letters. ## Anya C. Harry -S 2014.03.05 14:10:51 -05'00' , - Fran This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete. and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (1/14) SC Datalishing Sansaies (101) 441-6740 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {8}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K131912 Device Name ConchaTherm Neptune Heated Humidifier #### Indications for Use (Describe) The ConchaTherm® Neptune® is a respiratory humidifier designed to heat and humidify respiratory gases delivered via endotracheal tubes, nasal cannula or face masks to adult, pediatric, infant and neonatal patients. This system may be used with either conventional (non-heated wire) breathing circuits or compatible (21-volt) Hudson Respiratory Care Incorporated (RCI) heated-wire circuits. The ConchaTherm® Neptune® can be used with ventilators, continuous flow systems, oxygen diluters and blenders, adjustable nebulizer adapters for aerosol therapy, or non-flammable anes to help maintain patient body temperature. | | Comments of the contribution of the first and the program and the program and the comments of the comments of ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | Type of Use (Select one or both, as applicable) | | | | | | | | | | 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY . . . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) # Anya C. Harry -S 2014.03.05 14:07:24 -05'00' This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov * An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (1/14) PSC Publishing Services (NDI) 443-46740 EF Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. Page 1 of 1